Identity
- Trade Name
- Phadebact CSF Test FDA UDI
- Generic Name
- Multiple meningitis-associated bacteria antigen IVD, kit, agglutination FDA UDI
- Model / Reference
- 10-5592-12 FDA UDI
Identifiers
- Catalog Number
- 10-5592-12 FDA UDI
- Primary DI / UDI-DI
- 07350049850221 FDA UDI
- FDA Product Code
- GTJ FDA UDI
- GMDN Term
- Multiple meningitis-associated bacteria antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
Phadebact CSF Test by Mkl Diagnostics AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mkl Diagnostics AB
Sources (1)
- FDA UDI 8337d3db-7df1-4740-97d8-05647a8abf99 35 fields · synced May 30, 2026